Veteran-Centered Care for Advanced Liver Disease

(Vet-CALD Trial)

Recruiting at 4 trial locations

Overseen By Fasiha Kanwal, MD MSHS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Non-veterans, Advanced cancer, Schizophrenia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 6 months

450 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help Veterans with advanced liver disease by using a personalized approach to improve their care. It seeks to align treatment options with each patient's understanding of their condition and personal healthcare goals, potentially increasing their chances for a liver transplant and enhancing serious illness discussions. Participants will either receive standard care or have additional sessions with a care counselor via video or phone. This trial may suit Veterans who have been dealing with liver-related health issues and have had at least one medical visit in the last two years. As an unphased trial, it offers Veterans a unique opportunity to contribute to innovative care strategies tailored to their needs.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this Veteran-centered care approach is safe for patients with advanced liver disease?

Research has shown that the I-VCALD treatment for advanced liver disease includes sessions with a care counselor. This method helps patients understand their condition and set health goals. Without medication, it avoids typical drug-related side effects. No problems have been reported from these counseling sessions. The focus on improving communication and planning is generally very safe. Participants can expect these sessions to be manageable, as they primarily involve discussion and planning support. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Veteran-Centered Care for Advanced Liver Disease approach because it personalizes treatment for veterans with advanced liver disease. Unlike the standard of care, which primarily involves routine medical management, this approach integrates regular sessions with a care counselor. These sessions are designed to help patients better understand their illness and set personal healthcare goals, ensuring that treatment plans are tailored to their individual needs and priorities. By involving a dedicated counselor who works alongside a centralized research care team and the patient's usual VA care providers, this method aims to enhance patient engagement and potentially improve outcomes.

What evidence suggests that this trial's treatments could be effective for advanced liver disease?

This trial will compare the I-VCALD method with usual care for Veterans with advanced liver disease. Research has shown that I-VCALD, which participants in this trial may receive, could enhance care by focusing on the whole person, helping patients better understand their illness, and aligning care with personal goals. Studies have found that this approach can increase the likelihood of being considered for a liver transplant and encourages important conversations about serious illnesses that are often overlooked. Early results suggest this method may lead to more personalized and effective care for those with advanced liver disease. ^{1 2 3 5 6}

Who Is on the Research Team?

Anne M Walling, MD PhD

Principal Investigator

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Steven M. Asch, MD MPH

Principal Investigator

VA Palo Alto Health Care System, Palo Alto, CA

Fasiha Kanwal, MD MSHS

Principal Investigator

Michael E. DeBakey VA Medical Center, Houston, TX

Are You a Good Fit for This Trial?

This trial is for Veterans aged 18-80 with advanced liver disease who have been in care at a recruiting site for over a year. They must speak English, have phone or computer access, and be able to consent. Those already on the transplant list or with limited life expectancy are excluded.

Inclusion Criteria

I have advanced liver disease with recent complications or a MELD-Na score over 15.

You must be a Veteran to qualify.

You have been under the care of one of the participating sites for at least 12 consecutive months, including two or more visits to your primary healthcare provider.

Exclusion Criteria

I have been diagnosed with uncontrolled mental health issues or schizophrenia.

Non-Veteran patients

Patients with very limited life expectancy (advanced cancer, acute-on-chronic liver failure, and hospice patients)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Vet-CALD intervention, which includes 5 monthly 60-minute care counselor sessions over 6 months via telehealth

6 months

5 visits (virtual)

Follow-up

Participants are monitored for changes in consideration for liver transplantation and goals of care conversations

12 months

What Are the Treatments Tested in This Trial?

Interventions

• I-VCALD

Trial Overview The I-VCALD study tests a telemedicine-based approach where nurses help Veterans understand their illness, identify care preferences, and align treatment options. It aims to increase rates of liver transplant consideration and serious illness discussions.

How Is the Trial Designed?

Group I: Arm 1: Vet-CALD Intervention Experimental Treatment 1 Intervention

Vet-CALD Participants will receive the standard of care from their usual VA healthcare provider, plus they will participate in 5 monthly 60-minute care counselor sessions over a period of 6 months via VA Video Connect (VVC) or by telephone. The purpose of care counselor visits is to assess and cultivate the patient's understanding of their illness and identify personal healthcare goals. The counselor will be part of a centralized research care team (hepatologist and supportive care physician) and will work with each patient's usual VA care providers to help tailor treatment plans and education to better align with each patient's understanding of their disease prognosis and their healthcare goals and priorities.

Group II: Arm 2: Usual Care Active Control 1 Intervention

Usual Care Participants will receive the standard of care from their usual VA healthcare provider. The care counselor will not contact the usual care condition participants.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

Advanced liver disease (AdvLD) is a serious condition that often leads to significant morbidity and mortality, yet there is a lack of access to effective supportive and palliative care despite available treatments.

The development of a patient-centered integrated care model for AdvLD is essential, as it would enable better collaboration among clinicians, patients, and caregivers to align treatments with patients' priorities and improve overall care outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrated Model for Patient-Centered Advanced Liver Disease Care. Naik, AD., Arney, J., Clark, JA., et al.[2022]

Implementing a hepatologist-led advance care planning intervention significantly increased advance directive (AD) completion rates from 8% to 31% and goals of care discussion (GCD) rates from 0% to 51% among 62 patients with decompensated cirrhosis.

The intervention highlighted that women and nonmarried adults showed greater improvements in AD completion, while providers identified time constraints as a major barrier to advance care planning discussions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving Advance Care Planning in Outpatients With Decompensated Cirrhosis: A Pilot Study. Patel, A., Kogekar, N., Agarwal, R., et al.[2021]

A study involving 106 Veterans Health Administration facilities identified 35 out of 73 implementation strategies that were positively correlated with improved, evidence-based cirrhosis care, highlighting effective practices for managing this condition.

Qualitative interviews with top-performing facilities revealed eight core strategies essential for enhancing cirrhosis care, suggesting that these findings could help address similar challenges in other areas of liver health management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Core implementation strategies for improving cirrhosis care in the Veterans Health Administration. Yakovchenko, V., Morgan, TR., Miech, EJ., et al.[2023]

A national survey of 153 Veterans Health Administration sites revealed that while over 80% offer multidisciplinary services for advanced liver disease (ALD), less than 25% provide pharmacologic treatment for alcohol use disorder, indicating a gap in comprehensive care.

Despite the availability of palliative care services, 61% of sites reported referring fewer than 25% of ALD patients for these services, highlighting a significant opportunity to improve patient support and care coordination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Access to Comprehensive Services for Advanced Liver Disease in the Veterans Health Administration. Dunn, SH., Rogal, SS., Maier, MM., et al.[2022]

Chronic liver disease requires a multifaceted approach in primary care, focusing on education, counseling, and harm reduction, as well as monitoring for cirrhosis and its complications.

For patients with advanced liver disease, comprehensive care should include potential referral for liver transplantation and prioritizing patient goals for care and symptom relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comprehensive Care of Patients with Chronic Liver Disease. James, J., Liou, IW.[2015]

Advance care planning (ACP) and goals of care designation (GCD) are crucial for patients with cirrhosis, yet their adoption has been limited due to perceived barriers by physicians.

The authors provide a practical framework with tools like conversation starters and educational resources tailored for cirrhosis patients, which has successfully increased patient engagement in GCD discussions before health crises.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advance care planning (ACP) for specialists managing cirrhosis: A focus on patient-centered care. Brisebois, A., Ismond, KP., Carbonneau, M., et al.[2018]

The nurse-led Care Coordination of Liver Disease (CCoLD) clinic significantly reduced unplanned liver-related readmissions to 2.08% compared to 12.2% in the standard care group, indicating improved patient outcomes.

Mortality rates at 30 days were also lower in the CCoLD cohort (0%) compared to the control group (7.3%), demonstrating the efficacy of integrated care in managing patients with advanced chronic liver disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel, nurse-led 'one stop' clinic for patients with liver cirrhosis results in fewer liver-related unplanned readmissions and improved survival. Kalo, E., Baig, A., Gregg, E., et al.[2023]

Over 70% of Medicare beneficiaries with advanced liver disease died during the study period from 2005 to 2009, highlighting the high mortality associated with this condition.

Key predictors of mortality included admission to the intensive care unit (ICU) and a higher Charlson Comorbidity Index, while ICU admission and thoracentesis procedures were linked to increased hospital length of stay and costs, indicating the severity of illness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resource utilization and survival among Medicare patients with advanced liver disease. Otgonsuren, M., Henry, L., Hunt, S., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06068491

Veteran-Centered Care for Advanced Liver Disease (Vet ... Project Objectives: The overall goal of the Vet-CALD project is to develop and test a novel sustainable Whole Health program in caring for patients with AdvLD.

2. trialx.com trialx.com/clinical-trials/listings/306231/veteran-centered-care-for-advanced-liver-disease-vet-cald/

Veteran-Centered Care for Advanced Liver Disease (Vet-CALD) Study outcomes include changes in (1) rates of consideration for liver transplantation, and (2) completion of serious illness discussions. Findings will inform ...

3. withpower.com withpower.com/trial/phase-liver-diseases-9-2024-d137a

Veteran-Centered Care for Advanced Liver Disease Study outcomes include changes in (1) rates of consideration for liver transplantation, and (2) completion of serious illness discussions. Findings will inform ...

4. research.va.gov research.va.gov/about/funded_research/proj-details-FY2024.cfm?pid=749632

Integrating Veteran-Centered Care for Advanced Liver ... Integrating Veteran-Centered Care for Advanced Liver Disease (I-VCALD). Principal Investigator: Fasiha Kanwal. Location: Houston, TX. Congressional District ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9319576/

Integrated Model for Patient-Centered Advanced Liver ... An integrated model of AdvLD would allow clinicians, patients, and caregivers to work collaboratively to identify treatments and other healthcare that best ...

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06068491/veteran-centered-care-for-advanced-liver-disease-vet-cald?page=3&id=1003&slug=primary-biliary-cholangitis

Veteran-Centered Care for Advanced Liver Disease (Vet ... Study outcomes include changes in (1) rates of consideration for liver transplantation, and (2) completion of serious illness discussions.